By Kurt R. Karst – In a decision and accompanying Order handed down on March 27, 2012, Judge Richard J. Leon of the U.S. District Court for the District of Columbia ordered that FDA “immediately notify any and all state correctional departments which it has reason …
By JP Ellison – We previously reported on the oral arguments in the Supreme Court case Sackett v. EPA that raised the question of when agency action was sufficiently final to allow a party to seek review in federal court. Earlier this week the Supreme Court …
By Ricardo Carvajal – In a letter that includes fun facts about the function of the epiglottis, FDA has warned Breathable Foods, Inc. that its AeroShot product is misbranded. The product’s labeling is alleged to be false and misleading because it contains contradictory statements regarding whether …
By Riëtte van Laack & John R. Fleder – After the Federal Trade Commission (“FTC”) entered consent orders against Nestle and Iovate (see here), prohibiting future claims for respondents’ food and dietary supplements unless they are supported by two well-controlled clinical studies, the industry has been …
By Kurt R. Karst – Among the Warning Letters FDA posted on its website this week, one in particular caught our attention – a February 17, 2012 Warning Letter to Merck Sharp and Dohme Corp. (“Merck”) citing a violatation of FDC Act § 505(o)(3). FDA’s enforcement …
By Kurt R. Karst – Following a long court battle in which a three-judge panel of the U.S. Court of Appeals for the Tenth Circuit affirmed a November 2010 decision from the U.S. District Court for the District of Wyoming granting FDA’s Motion to Dismiss a …
By JP Ellison – An important issue relating to when an action by an administrative agency can be challenged in court was argued before the Supreme Court last week. The case involved administrative enforcement activities of the U.S. Environmental Protection Agency (“EPA”). The case, Sackett v. …
By Susan J. Matthees – Earlier this week, the U.S. Court of Appeals for the District of Columbia Circuit affirmed the U.S. District Court for the District of Columbia’s decision granting FDA’s Motion to Dismiss a lawsuit filed in April 2010 by a group of ear …
By JP Ellison – We have previously posted both on FDA’s renewed focus on misdemeanor prosecutions of “responsible corporate officers” under the Park doctrine generally, and on the use of that doctrine against four Synthes executives (see here, here, here, here, and here). Two recent opinions …
In a new Legal Backgrounder published by the Washington Legal Foundation, Hyman, Phelps & McNamara, P.C.’s Karla L. Palmer and Jeffrey N. Gibbs write that a recent Florida federal district court ruling in United States v. Franck’s Lab, Inc., if upheld on appeal, will have …
By Ricardo Carvajal – On November 18, the United States District Court for New Jersey granted FTC’s motion for a finding that Lane Labs violated an order agreed to by the parties in 2000. In part, that order requires Lane Labs’ health-related marketing claims to be …
By Kurt R. Karst – We had hoped that our post from earlier this week, titled Pending DESI Program Proceedings – The List, would stimulate some discussion. And it did. One comment in particular that we received from an authoritative source caught our attention and deserves greater …
By Kurt R. Karst – For years we’ve heard rumors of a relatively current list, compiled by FDA, of proceedings pending under the Drug Efficacy Study Implementation (“DESI”) program. At one time, in the early 1980s, the list was included as an addendum to the Orange …
By Ricardo Carvajal - Recent FDA actions suggest that dietary supplement firms who fail to correct deficiencies in their GMP’s do so at their peril. For example, FDA recently filed a complaint for permanent injunction against ATF Fitness Products, Inc. et al. ("ATF"), a manufacturer and …
By Anne K. Walsh – On November 2, 2011, DOJ’s Assistant Attorney General Tony West gave a keynote address at the Twelfth Annual Pharmaceutical Regulatory and Compliance Congress in Washington, DC. During that speech, he touted DOJ’s “successes” against health care fraud achieved during the last …
